Device, system and method for multiple core biopsy

Abstract

A core biopsy device having a forward-facing cutting edge with either single or dual counter rotating blades is configured to acquire multiple biopsy specimens and temporarily store them within a specimen chamber located beneath the cutting edge. The core biopsy device is insertable and removable from a biopsy channel of an endoscope. The core biopsy device includes an endoscopically visible ruler with depth gauge increments. Other embodiments include deployable depth stops to restrain the plunging of the specimen chamber to not exceed distances preset or selected by the user. Multiple samples contained within the specimen chamber are removed via flushing from a syringe adapter when the device is removed from the endoscope. Alternatively the multiple specimens are removed under applied suction to an external chamber located outside the patient. The order and orientation of the removed specimens are preserved.

1 . A biopsy device operable through an endoscope by a user comprising:
 a flexible sheath having a terminus with a distal chamber configured with a forward facing cutting edge comprising a fixed blade and at least one movable blade; and   a manipulation end controllable by the user to plunge the forward facing cutting edge at a set depth or a depth selected by the user and to engage a cutting action by the at least one movable blade at the set depth or the depth selected to acquire a plurality of specimens storable in the distal chamber.   
     
     
         2 . The biopsy device of  claim 1 , wherein the fixed blade and the at least one movable blade are configured perpendicular to the long axis of the chamber. 
     
     
         3 . The biopsy device of  claim 1 , wherein the fixed blade and the at least one movable blade are configured angular to the long axis of the chamber. 
     
     
         4 . The biopsy device of  claim 1 , wherein the at least one movable blade is pivotable about a single axis. 
     
     
         5 . The biopsy device of  claim 1 , wherein the at least one movable blade comprises two counter rotating blades configured perpendicular to the long axis of the chamber and pivotable about a single axis shared between the two counter rotating blades. 
     
     
         6 . The biopsy device of  claim 1 , wherein the at least one movable blade comprises two counter rotating blades configured angular to the long axis of the chamber and pivotable about a single axis shared between the two counter rotating blades. 
     
     
         7 . The biopsy device of  claim 1 , wherein the at least one movable blade comprises two counter rotating blades configured perpendicular to the long axis of the chamber, each counter rotating blade configured to pivot from a separate axis. 
     
     
         8 . The biopsy device of  claim 1 , wherein the at least one movable blade comprises two counter rotating blades configured angular to the long axis of the chamber, each counter rotating blade configured to pivot from a separate axis. 
     
     
         9 . The biopsy device of  claim 1 , wherein the forward facing cutting edge includes a wire spanning across the middle of the forward facing cutting edge and a plate beneath the wire, wherein the plurality of specimens are cut the long axis to form a plurality of specimen half pairs, the specimen half pair kept separated by the plate. 
     
     
         11 . The biopsy device of  claim 1 , wherein the at least one moveable blade is initiated by a pulling action from the manipulation end. 
     
     
         12 . The biopsy device of  claim 1 , wherein the at least one moveable blade is initiated by a pushing action from the manipulation end. 
     
     
         13 . The biopsy device of  claim 1 , wherein the set depth or the depth selected is effected by the deployment of depth stops from the flexible sheath adjacent to the distal chamber initiated from the manipulation end. 
     
     
         14 . The biopsy device of  claim 1 , wherein the manipulation end includes a proximal chamber in fluid communication with the distal chamber, the proximal chamber configured to receive the plurality of specimens in the order and orientation acquired upon exposure of a suction conveyed through the flexible sheath. 
     
     
         15 . The biopsy device of  claim 1 , wherein the plurality of specimens are removed from the distal specimen chamber by a flushing fluid conveyed from the manipulation end with preservation of specimen order and orientation. 
     
     
         16 . A biopsy system operable through an endoscope by a user comprising:
 a flexible sheath having a terminus with a distal chamber configured with a forward facing cutting edge comprising a fixed blade and at least one movable blade; an   a manipulation end controllable by the user to plunge the forward facing cutting edge at a set depth or a depth selected by the user and to engage a cutting action by the at least one movable blade at the set depth or the depth selected to acquire a plurality of specimens storable in the distal chamber; and   a proximal chamber in fluid communication with the distal chamber, the proximal chamber configured to receive the plurality of specimens in the order and orientation acquired upon exposure of a suction conveyed through the flexible sheath.   
     
     
         17 . The biopsy system of  claim 16 , wherein the fixed blade and the at least one movable blade are configured perpendicular to the long axis of the chamber. 
     
     
         18 . The biopsy system of  claim 16 , wherein the fixed blade and the at least one movable blade are configured angular to the long axis of the chamber. 
     
     
         19 . The biopsy system of  claim 16 , wherein the at least one movable blade is pivotable about a single axis. 
     
     
         20 . The biopsy system of  claim 16 , wherein the at least one movable blade comprises two counter rotating blades configured perpendicular to the long axis of the chamber and pivotable about a single axis shared between the two counter rotating blades. 
     
     
         21 . The biopsy system of  claim 16 , wherein the at least one movable blade comprises two counter rotating blades configured angular to the long axis of the chamber and pivotable about a single axis shared between the two counter rotating blades. 
     
     
         22 . The biopsy system of  claim 16 , wherein the at least one movable blade comprises two counter rotating blades configured perpendicular to the long axis of the chamber, each counter rotating blade configured to pivot from a separate axis. 
     
     
         23 . The biopsy system of  claim 16 , wherein the at least one movable blade comprises two counter rotating blades configured angular to the long axis of the chamber, each counter rotating blade configured to pivot from a separate axis. 
     
     
         24 . The biopsy system of  claim 16 , wherein the forward facing cutting edge includes a wire spanning across the middle of the forward facing cutting edge and a plate beneath the wire, wherein the plurality of specimens are cut the long axis to form a plurality of specimen half pairs, the specimen half pair kept separated by the plate. 
     
     
         25 . A biopsy device having a removable stylet, the biopsy used operable by a person used with an image-guided system comprising:
 a rigid sheath equipped with the removable stylet, the rigid sheath having depth markings visible by the image-guided system and a terminus with a distal chamber configured with a forward facing cutting edge comprising a fixed blade and at least one movable blade; and   a manipulation end controllable by the user to plunge the forward facing cutting edge at a sampling locus after removal of the stylet at a depth selected by the user based on the depth markings and to engage a cutting action by the at least one movable blade at the depth selected to acquire at least one specimen storable in the distal chamber.   
     
     
         26 . The biopsy device of  claim 20 , wherein additional specimens may be acquired at deeper depths at the sampling locus. 
     
     
         27 . A method to acquire biopsy specimens from a region-of-interest using a system operable through the internal or external biopsy channel of an endoscope tube residing internally within a patient manipulatable by a user, the method comprising:
 inserting a flexible sheath fitted with a specimen chamber fitted with a forward facing cutting edge through and beyond the terminus of the biopsy channel to place the specimen chamber near the region-of-interest;   manipulating the specimen chamber via a handle in mechanical contact with the specimen chamber to deploy a plurality of depth stops and extend the specimen chamber beyond the terminus of the flexible sheath at a set or selected distance by the user;   plunging the specimen chamber forward facing cutting edge into tissues occupying the region-of-interest to the set or selected distance;   acquiring and storing a plurality of specimens in the specimen chamber; and   procuring the plurality of specimens from the specimen chamber in the order and orientation acquired.